Collaboration on Environmental Risk Assessment in the Northern Zone

Northern Zone: Denmark, Estonia, Finland, Iceland*, Latvia, Lithuania, Norway and Sweden. * Not permanent in Northern Zone Ecotox Gr.

Field studies The acceptability/representativeness of field studies for non-target arthropods and soil organisms should be assessed for each MS Earthworms and other soil organisms LogKow > 2: endpoints should be divided by 2 even with study soils containing orgM <10%, unless accepted documentation is provided

QSAR A QSAR endpoint for a metabolite can be accepted if it has been accepted at EU level

Terrestrial organisms

ECOTOX

• PECtwa not accepted in acute risk assessment

• Geometric mean should always be assisted by WoE

approach

• Fish, long-term: geometric mean or median HC5 is

not accepted

• Invertebrate, long-term: for the geometric mean derivation only EC10 from LoEP are accepted

• Mesocosm studies: RAC shall be based on Ecological

Threshold Option (ETO); except DK (ERO)

• Ecological modelling: not accepted until agreed

models available at EU level

Mitigation Risk mitigation measures for each NZ MS should be presented based on country specific scenarios

Birds and Mammals

First tier risk assessment

• EFSA Guidance Document (2009)

• Maize (late BBCH): Willow Warbler should be added to the list of species

• If the first tier risk assessment indicates risk, higher tier…

Harmonised approach considering:

• Crop and growth specific focal species, e.g. skylark, white wagtail and brown hare

• PD

• PT

• Residue levels and decline in food items

• Use of interception and dehusking data

• Non acceptance of refinements based on body burden- or ecological modelling until validated models and guidance are available at European level

This poster presents work and challenges in the Northern Zone (NZ) to harmonise the zonal approach for authorisation of plant protection products (PPP) according to 1107/2009. Close collaboration is established in response to short timelines, more complicated environmental risk assessments (ERA) and limited resources. Harmonisation requires establishment of expert fora among member states (MS) and development of common guidance that are of use to both applicants and risk assessors.

The NZ guidance documents (NZ, 2016 a) cover the areas where the NZ has developed specific guidance on ERA. Some of the scientific issues that have been in focus for zonal harmonisation in the NZ are highlighted below.

Introduction

Harmonising the ERA among NZ MS has many advantages: • consistent scientific requirements among NZ MS more of the ERA can be

placed in the core RR • the dRR is easier for applicants to make easier for the MS to assess • fewer mistakes, due to agreed review process by cMS • may serve as inspiration for other MS in the CZ and SZ

Higher tier risk assessment

• Northern Zone guidance document for birds and mammals (NZ, 2016 b)

• A spreadsheet is available to facilitate calculations with agreed refinements

• Available at the Danish EPA web: http://eng.mst.dk/media/165037/bird-mammal-scenario-template-v10-4.xlsm

Harmonised higher tier refinements for NZ risk assessment, if a Tier 1 risk assessment following EFSA Aquatic GD (2013) does not address the risk.

Aquatic organisms

FATE

Refinements based on time variable exposures (e.g. pulse durations and/or intervals between pulses) are not accepted

• high uncertainty with FOCUS peaks

• pulsed exposure highly species specific and dependent on sensitive life stages and/or different life strategies

By Northern Zone Ecotox Expert Group, 2016.

Contact: Alf Aagaard, Danish EPA, Pesticides and Gene Technology (aaa@mst.dk).

Non-target plants

• Interception as refinement for lowering

the exposure not accepted

• MAF is applied according to Escort 2

• SSD: requires at least 10 species

• Deterministic risk assessment if HC5

exceeds the EC50 of the most sensitive species in the SSD

Burns M, Reichenberger S, Pires J, Tripault H, 2015. How representative are the Northern groundwater scenarios of the actual conditions in the Northern zone? Report of a study commissioned by the Danish Environmental Protection Agency and financed by the Nordic Council of Ministers. v. 1.1. 124 p. EFSA, 2009. Risk assessment for birds and mammals, EFSA Journal 2009; 7(12): 1438 EFSA, 2013. Guidance on tiered risk assessment for plant protection products for aquatic organisms in edge-of-field surface waters, EFSA Journal 2013; 11(7): 3290 FI, 2011. http://www.tukes.fi/pecsoilcalculator Geosigma, 2013. Comparison of Northern Zone Groundwater Models. NZ, 2016 a. Guidance document on work-sharing in the northern zone in the authorisation of plant protection products. Ver 5. April 2016. NZ, 2016 b. Pesticide risk assessment for birds and mammals, Selection of relevat species and development of standard scenarious for higher tier risk assessment in the Northern Zone in accordance with Regulation EC 1107/2009

References

PECgw • 9 scenarios are used in the Northern Zone (2 EU FOCUS

and 7 national MACRO scenarios) • Two “groundwater projects” have been conducted (2013

and 2015) find out if some scenarios could cover several MS’s (rank scenarios and identify a worst case) and reduce the number of scenarios required for the NZ. Results: • Scenarios not very representative for true soil and

climate conditions in the zone. Largely due to the age of the weather data and deficient soil characteristic data But the scenarios were protective

• Not possible to rank the scenarios from best to worst since ranking depended on substance properties No harmonisation of a worst case scenario (tier 1)

• Harmonisation after groundwater projects: NO and SE agreed on 4 scenarios (3 SE and 1 NO scenarios)

PECsoil • The “Finnish PECsoil calculator”

is common for all MS • A new “Nordic PECsoil

calculator” which can handle both SFO, DFOP and FOMC kinetics is being developed. The calculator provides all output needed for the assessment

PECsw – risk mitigation measures

• All MS that require R-scenarios use a 10 m vegetative filter strip as risk mitigation

• Drift buffer zones are not harmonised

• Drift reducing nozzles is not an option in all MS Projects needed to implement this measure in MS

Environmental exposure